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临床试验 NCT07427121 (REHAB-MV) 针对Inspiratory Strength Training (IST)，Transcutaneous Spinal Stimulation，Sham Spinal Stimulation目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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Rehab and Mechanical Ventilation (REHAB-MV) 16

尚未招募
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临床试验NCT07427121 (REHAB-MV)是一项针对Inspiratory Strength Training (IST)，Transcutaneous Spinal Stimulation，Sham Spinal Stimulation的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月10日开始，预计招募16名患者。该研究由佛罗里达大学主导，计划于2027年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月27日。
简要概括
The goal of this research study is to evaluate the effects of a single session of rehabilitation in healthy adults, before noninvasive mechanical ventilation (MV). MV can help support breathing function during sleep or illness. High levels of MV support have been reported to alter the function of the diaphragm muscle, the primary breathing muscle, in people with compromised health. However, rehabilitation may have so...显示更多
详细描述
Brief periods of mechanical ventilation (MV) can degrade the function of the diaphragm, which can be a problem for older adults and people with multiple medical comorbidities. 20% of people who are placed on MV require a prolonged effort to wean back to independent breathing. The effects of MV on respiratory neural function are often unaddressed by typical clinical practices. Many aspects of clinical practice such as...显示更多
官方标题

Rehabilitation-based Approaches to Prevent Mechanical Ventilation-induced Breathing Dysfunction

疾病
Inspiratory Strength Training (IST)Transcutaneous Spinal StimulationSham Spinal Stimulation
出版物
关于此临床试验发表的科学文章和研究论文：
其他研究标识符
  • REHAB-MV
  • IRB202501849
NCT编号
NCT07427121
实际开始日期
2026-03-10
最近更新发布
2026-02-27
预计完成日期
2027-12-31
计划入组人数
16
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
diaphragm
phrenic nerve
maximal inspiratory pressure
mechanical ventilation
主要目的
治疗方法
分配方式
随机
干预模型
交叉设计
盲法
双盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
模拟对照Sham Stimulation
Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.
假刺激
Transcutaneous spinal cord stimulation at reduced intensity, lasting 1 minute at the beginning and end of a 20-minute session.
阳性对照Spinal cord stimulation
Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
脊髓刺激
Transcutaneous spinal cord stimulation at 2mA intensity, for 20 minutes.
实验性Inspiratory strength training
5 sets of 5 breaths of high-intensity inspiratory strength training
Inspiratory Strength Training
5 sets of 5 breaths of high-intensity inspiratory strength training
主要终点
结果指标度量标准描述时间框架
Maximal inspiratory pressure
The most negative pressure generated during a maximal inspiratory effort.
T1: baseline strength, T2: 2 hours after MV, T3: 24 hours after MV
Phrenic CMAP Response
EMG response to supra maximal and bilateral phrenic stimulation
up to 24 hours
次要终点
结果指标度量标准描述时间框架
Diaphragm thickness and excursion
Diaphragm thickness and excursion will be computed during resting breathing and during inspiratory efforts.
up to 24 hours
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
25 Years
适龄性别
全部
接受健康志愿者
是

Non-smokers Sedentary or recreationally active Normal lung function No history of claustrophobia

Current smoking or vaping Obstructive lung disease Use of antibiotics or systemic corticosteroids to treat an acute condition History of sepsis or metastatic disease Post infectious conditions that affect breathing Diagnosed with a neurological or neuromuscular condition Any use of supplemental oxygen, continuous positive airway pressure (CPAP), or other positive pressure ventilation to treat sleep apnea Cardiac disease Orthopedic conditions that impair lung expansion Pregnancy Implanted metallic devices within 10 cm of the cervical spine
University of Florida logo佛罗里达大学
研究中心联系人
联系人: Barbara K Smith, PhD, PT, 352-294-5315, [email protected]
联系人: Ushna Khan, MD, 352-273-6855, [email protected]
1 位于 1 个国家/地区的研究中心

Florida

University of Florida, Gainesville, Florida, 32610, United States